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Erythrocytapheresis Versus Phlebotomy as Maintenance Therapy in Hereditary Hemochromatosis (HH) Patients

Primary Purpose

Hereditary Hemochromatosis

Status
Unknown status
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Phlebotomy and erythrocytapheresis
Sponsored by
Sanquin Research & Blood Bank Divisions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hereditary Hemochromatosis focused on measuring Phlebotomy, Therapeutic erythrocytapheresis, Hereditary Hemochromatosis, maintenance therapy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • homozygous for C282Y
  • currently treated with phlebotomy as maintenance therapy for at least 6 month
  • ferritin level between 30-50 micog/L
  • age 18 years an older
  • weight more than 50 kg
  • signed informed consent
  • willingness to fill out additional questionnaires at three points in time

Exclusion Criteria:

  • chelating therapy
  • forced dietary regime
  • aged below 18 years
  • excessive overweight ( BMI more than 35)
  • pregnancy

Sites / Locations

  • University Hospital Maastricht

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Phlebotomy -intervention phlebotomy

Erythrocytapheresis

Arm Description

Patients are treated with phlebotomy if ferritin level >50 ug/l

Patients are treated with erythrocytapheresis if serum ferritin level >50ug/l

Outcomes

Primary Outcome Measures

The difference in number of required treatments and the interval between treatments per year to keep the serum ferritin levels between 30-50 microg/L

Secondary Outcome Measures

Full Information

First Posted
July 19, 2011
Last Updated
December 3, 2013
Sponsor
Sanquin Research & Blood Bank Divisions
Collaborators
Maastricht University Medical Center, Atrium Medical Center, Radboud University Medical Center, Orbis Medical Centre
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1. Study Identification

Unique Protocol Identification Number
NCT01398644
Brief Title
Erythrocytapheresis Versus Phlebotomy as Maintenance Therapy in Hereditary Hemochromatosis (HH) Patients
Official Title
Erythrocytapheresis Versus Phlebotomy as Maintenance Therapy in Patients With Hereditary Hemochromatosis; a Randomised, Single Blinded Sequential, Cross-over Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2008 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sanquin Research & Blood Bank Divisions
Collaborators
Maastricht University Medical Center, Atrium Medical Center, Radboud University Medical Center, Orbis Medical Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Hereditary hemochromatosis (HH) is a genetic disorder of iron metabolism, resulting in excessive iron overload. Phlebotomy is currently the standard therapy. More recently Therapeutic Erythrocytapheresis (TE) has become a new therapeutic modality, which potentially offers a more efficient method to remove iron overload with fewer procedures.In the proposed clinical trial the investigators will examine whether TE can keep the ferritin levels in patients requiring maintenance therapy below 50 microg/L, with minimally half the number of treatment procedures when compared to current standard therapy by P.
Detailed Description
The research population exists of patients with HH ( by genetic analysis confirmed as homozygous for C282Y) living in south-east of the Netherlands and currently treated with phlebotomy as maintenance treatment to keep their serum ferritin levels < 50 ug/l. Ferritin level at start of the inclusion between 30-50ug/l. Exclusion criteria are: patient receiving other therapies such as chelating therapy or forced dietary regimen, further patients with excessive overweight (BMI>35). After enrollment the patients will be randomized to start either with TE or continue with P. After a year of treatment and being at a serum ferritin level <50ug/l, patients will continue the study but then being treated with the other of the two treatments. Randomization will be done by blocked randomization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hereditary Hemochromatosis
Keywords
Phlebotomy, Therapeutic erythrocytapheresis, Hereditary Hemochromatosis, maintenance therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phlebotomy -intervention phlebotomy
Arm Type
Active Comparator
Arm Description
Patients are treated with phlebotomy if ferritin level >50 ug/l
Arm Title
Erythrocytapheresis
Arm Type
Experimental
Arm Description
Patients are treated with erythrocytapheresis if serum ferritin level >50ug/l
Intervention Type
Other
Intervention Name(s)
Phlebotomy and erythrocytapheresis
Intervention Description
Phlebotomy- removal of 500 ml whole blood Erythrocytapheresis- removal of 300-800 ml erythrocytes
Primary Outcome Measure Information:
Title
The difference in number of required treatments and the interval between treatments per year to keep the serum ferritin levels between 30-50 microg/L
Time Frame
one year after first phlebotomy treatment and one year after first erythrocytapheresis treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: homozygous for C282Y currently treated with phlebotomy as maintenance therapy for at least 6 month ferritin level between 30-50 micog/L age 18 years an older weight more than 50 kg signed informed consent willingness to fill out additional questionnaires at three points in time Exclusion Criteria: chelating therapy forced dietary regime aged below 18 years excessive overweight ( BMI more than 35) pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Rombout, MD
Organizational Affiliation
Sanquin Blood Supply
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Maastricht
City
Maastricht
ZIP/Postal Code
6300
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

Erythrocytapheresis Versus Phlebotomy as Maintenance Therapy in Hereditary Hemochromatosis (HH) Patients

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